There have not been any new drug approvals so far this week but the FDA granted a few new Orphan Drug Designations and Priority Reviews. Here is my summary of the top regulatory news stories this week for pharma and biotech: The FDA is on track for most generic drug approvals ever for Fiscal Year[…]
There were several guidance updates from the FDA this week along with several new medicine approvals by the EMA. And the anticipated FDA layoffs have been delayed for now. Here is my summary of the top regulatory stories this week: 1. FDA Commissioner Scott Gottlieb said he will delay issuing layoff notices until after September[…]
This was a relatively quiet regulatory news week when compared to the past few weeks. Here is my summary of the top stories to follow: The FDA approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer. https://www.firstwordpharma.com/node/1488664 The FDA approved Gilead’s VOSEVI, a three-drug combination of[…]
I am posting this week’s regulatory update a day early since our office will be closed tomorrow for the holiday weekend. Only one new molecular entity was approved this week, along with a couple of new indication approvals. The FDA approved Kevzara (sarilumab), a treatment of rheumatoid arthritis which was co-developed by Sanofi and Regeneron. […]
